Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study

Orkin, Chloe;DeJesus, Edwin;Ramgopal, Moti;Crofoot, Gordon;Cao, Huyen;et.al.
(2017) The Lancet HIV — Vol. 4, n° 5, p. e195-e204 (2017)

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  • Orkin, Chloe
    Author
  • DeJesus, Edwin
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  • Ramgopal, Moti
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  • Crofoot, Gordon
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  • Vandercam, BernardUCLouvain
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  • Cao, Huyen
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Abstract
Background Tenofovir alafenamide, a tenofovir prodrug, results in 90% lower tenofovir plasma concentrations than does tenofovir disproxil fumarate, thereby minimising bone and renal risks. We investigated the efficacy, safety, and tolerability of switching to a single-tablet regimen containing rilpivirine, emtricitabine, and tenofovir alafenamide compared with remaining on rilpivirine, emtricitabine, and tenofovir disoproxil fumarate. Methods In this randomised, double-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-1-infected adults were screened and enrolled at 119 hospitals in 11 countries in North America and Europe. Participants were virally suppressed (HIV-1 RNA <50 copies per mL) on rilpivirine, emtricitabine, and tenofovir disoproxil fumarate for at least 6 months before enrolment and had creatinine clearance of at least 50 mL/min. Participants were randomly assigned (1:1) to receive a single-tablet regimen of either rilpivirine (25 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) or to remain on a single-tablet regimen of rilpivirine (25 mg), emtricitabine (200 mg), and tenofovir disoproxil fumarate (300 mg), with matching placebo, once daily for 96 weeks. Investigators, participants, study staff, and those assessing outcomes were masked to treatment group. All participants who received one dose of study drug and were on the tenofovir disoproxil fumarate regimen before screening were included in primary efficacy analyses. The primary endpoint was the proportion of participants with less than 50 copies per mL of plasma HIV-1 RNA at week 48 (by the US Food and Drug Administration snapshot algorithm), with a prespecified non-inferiority margin of 8%. This study was registered with ClinicalTrials.gov, number NCT01815736.
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Orkin, C., DeJesus, E., Ramgopal, M., Crofoot, G., Ruane, P., LaMarca, A., Mills, A., Vandercam, B., de Wet, J., Rockstroh, J., Lazzarin, A., Rijnders, B., Podzamczer, D., Thalme, A., Stoeckle, M., Porter, D., Liu, H. C., Cheng, A., Quirk, E., et al. (2017). Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. The Lancet HIV, 4(5), e195-e204. https://doi.org/10.1016/s2352-3018(17)30031-0 (Original work published 2017)